GRAIL shares surge after FDA reviewers raise no major concerns on Galleri cancer test

• GRAIL (NASDAQ:GRAL) shares jumped after FDA staff reviewers identified no major concerns regarding the accuracy and safety of the Galleri multi-cancer detection test.
• The FDA advisory panel will review evidence supporting Galleri’s premarket approval application.
• Galleri is designed to detect signals from more than 50 cancer types through a single blood test.

GRAIL (NASDAQ:GRAL) shares rose sharply after U.S. Food and Drug Administration staff reviewers reported no major concerns regarding the safety and analytical performance of the company’s Galleri blood test designed to detect multiple cancers.

The FDA’s findings will be discussed by an external advisory panel reviewing GRAIL’s request for premarket approval of Galleri.

According to FDA briefing documents, agency reviewers did not identify outstanding questions related to analytical performance, study design or the primary safety analyses of the test.

However, advisers will discuss whether current evidence supports Galleri’s description as an “early detection” test.

Following the announcement, GRAIL's share price increased approximately 35% during Monday trading.

Galleri is a multi-cancer early detection (MCED) test that analyzes molecular signals released by tumors into the bloodstream through a single blood draw.

The test is designed to complement, rather than replace, existing cancer screening methods such as mammograms and colonoscopies.

GRAIL previously submitted its FDA application based on data from a U.S. clinical study, early results from a U.K. trial and an analysis comparing versions of the test.

The company’s shares had declined more than 20% since February after GRAIL reported that routine screening with Galleri did not significantly increase early detection or reduce late-stage diagnoses in a three-year U.K. trial.

Galleri is currently available under Clinical Laboratory Improvement Amendments (CLIA) regulations but does not yet have FDA approval.

FDA approval could support broader clinical adoption, inclusion in medical guidelines and potential insurance coverage.

The company reported that Galleri generated $136.8 million in U.S. revenue in 2025.